Approved Products_2004.xls
Number A pproval Date Trade Name Generic/ Chemical name Indication Company 1 Oct- 82 Humulin Human Insulin Type I Diabetes Lilly / Genentech 2 Oct- 85 Protro pin Human Growth Hormone Hypoptuitary dwarfism Genentech 3 Jun- 86 Intron A Interferon Al pha 2B Hairy Cell Leukemia Schering Plough / Biogen 4 Jun- 86 OKT- 3 Anti CD3 Mab Acute Trans plant Rejection JNJ / OrthoBiotech 5 Jun- 86...
author: Reijer
Prescription and Over-the-Counter Drug Product List: 12/2003
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, ACETAMINOPHEN AND CAFFEINE >A> + MIKART 750MG;50MG;40MG N40496 001 DEC 23, 2003 DEC NEWA ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE TABLET; ORAL DARVOCET A500 >D> + AAIPHARMA 500MG;100MG N76429 001 SEP 10, 2003 DEC CTNA >A> + 500MG;100MG N76429 001 SEP 10, 2003 DEC CTNA...
http://www.fda.gov/cder/orange/appendix_a.txt
3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE #3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE, ACETAMINOPHEN ACETAMINOPHEN, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN, BUTALBITAL AND CAFFEINE, ACETAMINOPHEN ACETAMINOPHEN,...
Prescription and Over-the-Counter Drug Product List: 2/2003
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL -A- CODRIX -A- + ANDRX PHARMS 500MG;15MG N40447 001 FEB 26, 2003 FEB NEWA AZATHIOPRINE TABLET; ORAL AZASAN -A- AAIPHARMA LLC 25MG N75252 002 FEB 03, 2003 FEB NEWA -A- AB 50MG N75252 001 JUN 07, 1999 FEB NEWA -A- 75MG N75252 003 FEB 03, 2003 FEB NEWA -A- 100MG N75252 004 FEB 03, 2003...
author: AUTHOR
Prescription and Over-the-Counter Drug Product List: 3/2003
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL FIORICET W/ CODEINE -D- AB + NOVARTIS 325MG;50MG;40MG;30MG N20232 001 JUL 30, 1992 MAR CAHN -A- AB + WATSON PHARMS 325MG;50MG;40MG;30MG N20232 001 JUL 30, 1992 MAR CAHN ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL CODRIX -A- + ANDRX PHARMS 500MG;30MG N40441 001...
author: AUTHOR
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BIO Citizen Petition (21 CFR § 10.30) Follow- on Therapeutic Proteins Biotechnology Industry Organization (BIO) 1225 Eye Street, NW, Suite 400 Washington, D 16 iv) Post- Hatch- Waxman Interpretations ............................... 3/ This document includes provisions that are at odds with the statute and long- standing agency interpretations of the FDCA forbidding...
duplicates:http://www.bio.org/link.asp?url=%2Freg%2FBIO%5FCP%2D%2DFINAL%5FDRAFT%5F4%5F22%5F03%2Epdf
DDPA May 1995
DEPARTMENT OF HEALTH AND HUMAN SERVICES, PUBLIC HEALTH SERVICE NDA NUMBER TRADE NAME APPLICANT ACTIVE INGREDIENT(S) APPROVAL DATE (DOSAGE FORM) STRENGTH(S) (CLASSIFICATION) CLASSIFICATION(S) ***ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS 19-915 MONOPRIL BRISTOL MYERS SQUIBB FOSINOPRIL SODIUM 02-MAY-95 (TABLET) PRINCETON, NJ 10MG (SUPPL-009) 08543 20MG 40MG (NEW INDICATION...
Teva Pharmaceutical Industries - News and PR
- - Search Tevapharm: - - Press Release Teva And Savient Launch Tev-Tropin For Pediatric Growth Hormone Deficiency Jerusalem, Israel, February 11, 2005 - Teva Pharmaceuticals Industries Ltd. launch of TEV-TROPIN (somatropin [rDNA origin] for injection), a growth hormone product for the treatment of children with short stature due to growth hormone...
http://www.microbix.com/PDFs/3487_Generic%20Biologics_rpt.pdf page 27
Approved Biotechnology Drugs, 2002
- Acutely decompensated congestive heart failure with shortness of breath at rest or with minimal activity - Aug 2001 Neulasta™ (pegfilgrastim) - Amgen - Reduction of incidence of infection as manifested by febrile neutropenia in non-myeloid cancer patients receiving certain chemotherapies - Jan 2002 Neumega® (oprelvekin) - Wyeth - Prevention of severe chemotherapy-induced...
Prescription and OTC Drug Product List 6/2002
-D- + WYETH AYERST 20,000 UNITS/VIAL N17055 003 JUN DISC -A- @ 20,000 UNITS/VIAL N17055 003 JUN DISC CHORIONIC GONADOTROPIN -D- + STERIS 2,000 UNITS/VIAL N17016 011 FEB 16, 1990 JUN DISC -A- @ 2,000 UNITS/VIAL N17016 011 FEB 16, 1990 JUN DISC GRANISETRON HYDROCHLORID E SOLUTION; ORAL KYTRIL -D- + ROCHE EQ 2MG BASE/10ML N21238 001 JUN 27, 2001 JUN DISC -A- @ EQ 2MG BASE/10ML N21238...
http://www.biovalley.com/biovalley/newsletter/pdf/0398.pdf
Key impulses from within the mosaic N E W S L E TT E R It is no coincidence that the name »BioValley« conjures up associations that remind one of another famous »Valley«. That region of California in which creative students and other computer fans started work two decades ago. The name has become synonymous ...
duplicates:http://www.biovalley.com/biovalley/news/newsletter/pdf/0398.pdf http://www.biovalley.com/biovalley/newsletter/pdf/news03/newsletter.pdf http://www.biovalley.com/news/newsletter/pdf/0398.pdf
Sitka - Overview
This contains the entire Sitka site in one document to facilitate simple printing. In 1987, he founded and became CEO of Xenova plc, an emerging bio -pharmaceutical company, which listed on NASDAQ in 1994, and the London Stock Exchange in 1996. Since leaving Xenova in 1998, he has held directorships in a number of private companies operating in the health and bio ...
http://www.biosis.org/ts/media/cdjournals/gazettenews/2001/CPG_News_0141.pdf
AstraZeneca has three new applications claiming azacyclic benzamide derivatives with opioid activity and potential in the treatment of pain, suggesting a possible replacement for the now defunct AR-M390 E OS 2001 and PATINNOVA, held at the Cardiff International Arena, coincide with this issue of the Gazette. Leland Hartwell has been an infrequent inventor too, but is named on...
http://www.biosis.org/ts/media/cdjournals/gazettenews/2002/CPG_News_0239.pdf
week 0239 27 Sept 2002 MMP 12 Inhibitors are at the center of a new cluster of six PCT applications from AstraZeneca, claiming their use in cancer, respiratory diseases, skeletal disorders and inflammation (See Page 4) ISSN:1464-3499 Drug Patenting in Context new national drug management Regulation which will ensure that all drug products new to the Chinese market undergo clinical...
Approved Products_2004.xls page 1
author: Reijer
Form 20F Registration page 34
author: BresaGen Limited
subject: Including US Sec Finance
duplicates:http://www.bresagen.com.au/pdf/form20Fregistration.pdf
BIOnews-12.99
BIOnews-12.99 GIT VERLAG 1 ! " # $$$$$$$$$$$$ % & ' ( $$$$$$ ) *(( + , $$$$$$$$ $$$$$$$$$$$$$ + $$$$$$$$$$$$$$$$$$$$$ $$$$$$$$$$$$$$$$$$ ...
author: Dr. Christian Velten
subject: BIOnews-12.99
BIOnews-12.99 page 1
BIOnews-12.99 GIT VERLAG 1 ! " # $$$$$$$$$$$$ % & ' ( $$$$$$ ) *(( + , $$$$$$$$ $$$$$$$$$$$$$ + $$$$$$$$$$$$$$$$$$$$$ $$$$$$$$$$$$$$$$$$ ...
author: Dr. Christian Velten
subject: BIOnews-12.99